A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease

NCT07168356 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 205872
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 2-part study where all participants will receive bepirovirsen. The study will measure how much bepirovirsen from a single dose gets into the blood, and how long it stays in the blood. The purpose of the study is to understand if blood levels of bepirovirsen are different in adults with kidney disease compared to healthy adults who do not have kidney disease.

Conditions

Hepatitis B

Keywords

Bepirovirsen; Pharmacokinetics; Severe renal impairment; Moderate renal impairment; Healthy participants; Renal function; Kidney disease; Hepatitis B

Outcome Measures

Primary Outcomes (2)

• Plasma Area Under the Concentration Time Curve From Time Zero (Pre-Dose) Extrapolated to Infinite Time [AUC(0-∞)] of Bepirovirsen

  Up to Day 50

• Maximum Observed Concentration (Cmax) of Bepirovirsen

  Up to Day 50

Secondary Outcomes (7)

• Plasma Area Under the Concentration Time Curve From Time Zero (Pre-Dose) to 24 hours [AUC(0-24)] of Bepirovirsen

  Up to 24 hours

• Plasma Area Under the Concentration Time Curve From Time Zero (Pre-Dose) to 168 hours (Day 8) [AUC(0-168)] of Bepirovirsen

  Up to 168 hours

• Observed Concentration of Bepirovirsen on Day 8

  At Day 8

• Apparent Terminal Phase Half-life (t1/2) of Bepirovirsen

  Up to Day 50

• Apparent Clearance (CL/F) of Bepirovirsen

  Up to Day 50

Study Arms (3)

Group 1- Severe Renal Impairment Participants

EXPERIMENTAL

Participants with severe renal impairment will receive Bepirovirsen.

Drug: Bepirovirsen

Group 2- Moderate Renal Impairment Participants

EXPERIMENTAL

Participants with moderate renal impairment will receive Bepirovirsen.

Drug: Bepirovirsen

Group 3-Healthy Control Participants

EXPERIMENTAL

Healthy control participants will receive Bepirovirsen.

Drug: Bepirovirsen

Interventions

Bepirovirsen DRUG

Bepirovirsen will be administered.

Group 1- Severe Renal Impairment Participants; Group 2- Moderate Renal Impairment Participants; Group 3-Healthy Control Participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 80 years, inclusive
• Body weight greater than or equal to 50 kilograms (kg) and body mass index (BMI) within the range 19 to 40 kilograms per square meter (kg/m\^2).
• Males and females may participate. Female participants must not be pregnant or breastfeeding, and must be of non-childbearing potential, or agree to use a highly effective method of contraception.
• Healthy, based on medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG).
• Normal renal function (eGFR adjusted for actual BSA greater than or equal to 90 ml/min)

You may not qualify if:

• Any medical condition that could affect the absorption, metabolism, or elimination of drugs, increase the risk of taking part in the study, or interfere with interpretation of the study data.
• History of vasculitis or any type of glomerulonephritis
• Use of creatine-containing supplements within 30 days of screening or intended use during the study.
• Current enrolment in another interventional study, or past participation in a study where an investigational medicine, vaccine or device was administered if, at the time of consent, it is within 5 half-lives or twice the duration of the biological effect (whichever is longer) of the product given in the previous study.
• Received any oligonucleotide or small interfering ribonucleic acid (siRNA) within the past 12 months.
• Exposure to more than 4 investigational products within the past 12 months.
• A positive blood test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
• Average weekly alcohol intake of greater than 14 drinks for males or greater than 7 drinks for females.
• Current substance misuse or dependence, or a previous history of substance misuse or dependence that could interfere with ability to participate in the study.
• History of renal transplantation or anticipated renal transplant during the study.
• On dialysis or likely to require dialysis during the study.
• Positive drug or alcohol screen.
• Urine albumin-to-creatinine ratio (uACR) \> 0.3 mg/mg (300 mg/g).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Tampa, Florida, 33603, United States

RECRUITING

MeSH Terms

Conditions

Hepatitis B; Renal Insufficiency; Kidney Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 11, 2025
• Study Start: September 16, 2025
• Primary Completion: April 28, 2026
• Study Completion (Estimated): August 18, 2026
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

US (1)